Electrical Nerve Block for Amputation Pain

• ClinicalTrials.gov Identifier: NCT02221934
• Recruitment Status: Recruiting
• First Posted: August 21, 2014
• Last Update Posted: June 18, 2020
• Sponsor: Neuros Medical, Inc.
• Information provided by (Responsible Party): Neuros Medical, Inc.

Tracking Information

• First Submitted Date: August 15, 2014
• First Posted Date: August 21, 2014
• Last Update Posted Date: June 18, 2020
• Actual Study Start Date: October 9, 2014
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 23, 2018)

• Primary Effectiveness Endpoint: Reduction of Pain Level by 50% from Baseline [ Time Frame: 3 months post implant ]
  Demonstration of 50% reduction in a Numerical Rating Scale (NRS) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).
• Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events [ Time Frame: From consent through 3 months post implant ]
  Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.

Original Primary Outcome Measures (submitted: August 19, 2014)

• Pain reduction after each treatment session as measured by Numerical Rating Scale [ Time Frame: 3 months post implant ]
• Incidence of all serious adverse events [ Time Frame: 3 months post implant ]

Current Secondary Outcome Measures (submitted: September 20, 2017)

• Secondary Effectiveness: Pain Relief after 2 hours [ Time Frame: 12 months post implant ]
  Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment
• Secondary Effectiveness: Pain Days per Week [ Time Frame: 12 months post implant ]
  Average number of pain days compared at Month 3, Month 6 and Month 12 to Baseline.
• Secondary Effectiveness: Pain Medication Use [ Time Frame: 12 months post implant ]
  Average morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
• Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL [ Time Frame: 12 months post implant ]
  Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.
• Secondary Effectiveness: Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]
  EQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.
• Secondary Effectiveness: Patient Global Impression of Change (PGIC) [ Time Frame: 12 months post implant ]
  Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits
• Secondary Safety [ Time Frame: 12 months post implant ]
  Incidence of all Non-Serious Adverse Events, including Non-Serious Adverse Events, Non-Serious Adverse Device Events, and Unanticipated (Non-Serious) Adverse Device Events from the time of consent through 12 months post implant.

Original Secondary Outcome Measures (submitted: August 19, 2014)

• Pain Medication Use [ Time Frame: 12 months post implant ]
• Pain interference to Activities of Daily Living (ADL) [ Time Frame: 12 months post implant ]
• Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]

Current Other Pre-specified Outcome Measures (submitted: September 20, 2017)

Exploratory Efficacy: Prosthetic Use [ Time Frame: 12 months post implant ]

Average hours of prosthetic use per week averaged across two weeks compared at Month 3, Month 6 and Month 12 to Baseline.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Electrical Nerve Block for Amputation Pain
• Official Title: High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
• Brief Summary: The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
• Detailed Description: The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Post-Amputation Pain
• Phantom Limb Pain
• Residual Limb Pain
• Stump Pain

Intervention

Device: Altius

Electrical signal

Study Arms

• Experimental: Signal more likely to block nerve
  Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block
  Intervention: Device: Altius
• Active Comparator: Signal less likely to block nerve
  Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block
  Intervention: Device: Altius

• Publications *: Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 22, 2018): 180
• Original Estimated Enrollment (submitted: August 19, 2014): 130
• Estimated Study Completion Date: September 2026
• Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Age ≥ 21 years old
• Unilateral amputated leg ≥ 12 months
• Chronic post amputation pain ≥ 6 months
• Pain episodes typically lasting ≥ 60 minutes
• Stable drug regimen ≥ 6 weeks
• No changes to medications or prosthesis for 3-month primary study period

Key Exclusion Criteria:

• Implanted with an active implantable medical device (i.e. pacemaker)
• Confounding source of pain that interferes with reporting of limb pain
• Uncontrolled diabetes
• Spasticity preventing full range of motion of involved side
• Extremely short stump; sits on end
• Untreated psychological condition (i.e. borderline personality)
• Condition requiring MRI studies or diathermy after device implant
• Life expectancy of less than 24 months
• Progressive neurological disease (i.e. multiple sclerosis)
• Subjects with active local or systemic infection or immunocompromised

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: David Veino; 440-951-2565 ext 124; dveino@neurosmedical.com

Contact: Gita Ghadimi; 440-951-2565 ext 180; gghadimi@neurosmedical.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02221934
• Other Study ID Numbers: 003-0001; QUEST Trial ( Other Identifier: Neuros Medical )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Neuros Medical, Inc.
• Study Sponsor: Neuros Medical, Inc.
• Collaborators: Not Provided

Investigators

• Principal Investigator: Leonardo Kapural, MD, PhD; Center for Clinical Research, Winston-Salem NC

• PRS Account: Neuros Medical, Inc.
• Verification Date: June 2020